scholarly journals Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jennifer Kettle ◽  
Chris Deery ◽  
Robert Bolt ◽  
Diana Papaioannou ◽  
Zoe Marshman
Keyword(s):  
General Anaesthesia ◽  
Health Professionals ◽  
Controlled Trial ◽  
Trial Registration ◽  
General Anaesthetic ◽  
Day Case ◽  
Internal Pilot ◽  
Barriers And Enablers ◽  
Stakeholder Perspectives ◽  
Recruitment Barriers

Abstract Background The ‘Melatonin for Anxiety prior to General anaesthesia In Children’ (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxious children (aged five to fourteen), undergoing day-case surgical procedures under general anaesthesia. Low recruitment is a challenge for many trials, particularly paediatric trials and those in ‘emergency’ settings. A qualitative study as part of MAGIC aimed to gather stakeholder perspectives on barriers and enablers to recruitment. Methods Sixteen stakeholders from six sites participated in semi-structured interviews about their experiences of setting up the MAGIC trial and recruiting patients as part of the internal pilot. Data was analysed using framework analysis. Results Participants identified barriers and enablers to recruitment. Barriers and enablers related to the study, participants, the population of anxious children, practitioners, collaboration with other health professionals, ethics, specific settings and the context of surgical day units and the wider health system. Attempting to recruit anxious children from a surgical day unit is particularly challenging for several reasons. Issues include the practicalities of dealing with a child experiencing anxiety for parents/guardians; professional unwillingness to make things more difficult for families and clinicians and nurses valuing predictability within a busy and time-sensitive setting. Conclusions Multi-site RCTs face recruitment barriers relating to study-wide and site-specific factors. There are multiple barriers to recruiting anxious children due to undergo day-case surgery. Barriers across domains can interrelate and reinforce each other, reflecting challenges relating to populations and settings. For example, in the case of anxious children, parents and other health professionals are concerned about exacerbating children’s anxiety prior to surgery. They may look for ways to keep things predictable and avoid the uncertainty of an RCT. Pre-trial engagement work could help address concerns among collaborating health professionals. Using rapid ethnography during set-up or an internal pilot to focus on how the protocol will be or has been operationalised in practice may help identify issues. Allowing time to reflect on the findings of internal pilots and implement necessary changes could facilitate higher recruitment during the main phase of a trial. Trial registration NIHR Trial Registration Number: ISRCTN18296119. Registered on October 01, 2019.

scholarly journals Efficacy of Low-Dose Epidural Anaesthesia in Surgery of the Anal Canal—A Randomised Controlled Trial

1994 ◽  
Vol 22 (2) ◽  
pp. 161-164 ◽  
Author(s):  
R. Kausalya ◽  
R. Jacob
Keyword(s):  
Anal Canal ◽  
General Anaesthesia ◽  
Low Dose ◽  
Controlled Trial ◽  
Effective Means ◽  
Patient Comfort ◽  
General Anaesthetic ◽  
Random Allocation ◽  
Advantages And Disadvantages ◽  
Randomised Controlled

The aim of the study was to compare in terms of patient comfort, surgical requirements and anaesthetic safety, the difference between epidural and general anaesthesia in patients undergoing surgery of the anal canal. The study was undertaken on 50 adult patients undergoing anal surgery. By random allocation 25 were given a general anaesthetic while 25 were given a low-dose epidural using 0.375% bupivacaine. Advantages and disadvantages of both methods were noted in the study. It was concluded that low-dose epidural is a more effective means of providing analgesia, while maintaining adequate sphincter tone for surgery on the anal canal, than general anaesthesia.

Stakeholder Perspectives on the Stigma of Suicide Attempt Survivors

Crisis ◽  
2017 ◽  
Vol 38 (2) ◽  
pp. 73-81 ◽  
Author(s):  
Lindsay L. Sheehan ◽  
Patrick W. Corrigan ◽  
Maya A. Al-Khouja ◽  
Keyword(s):  
Suicide Attempt ◽  
Health Professionals ◽  
Attempted Suicide ◽  
Community Based Participatory Research ◽  
Public Stigma ◽  
Suicide Method ◽  
Community Based ◽  
Stakeholder Perspectives ◽  
Personal Experiences ◽  
Prejudice And Discrimination

Abstract. Background: Past scholarly efforts to describe and measure the stigma surrounding suicide have largely viewed suicide stigma from the perspective of the general public. Aims: In the spirit of community-based participatory research (CBPR), the current study brought together a diverse stakeholder team to qualitatively investigate the suicide stigma as experienced by those most intimately affected by suicide. Method: Seven focus groups (n = 62) were conducted with suicide attempt survivors, family members of those who died by suicide, and suicide loss therapists. Results: Themes were derived for stereotypes (n = 30), prejudice (n = 3), and discrimination (n = 4). People who attempted suicide were seen as attention-seeking, selfish, incompetent, emotionally weak, and immoral. Participants described personal experiences of prejudice and discrimination, including those with health professionals. Conclusion: Participants experienced public stigma, self-stigma, and label avoidance. Analyses reveal that the stigma of suicide shares similarities with stereotypes of mental illness, but also includes some important differences. Attempt survivors may be subject to double stigma, which impedes recovery and access to care.

Experiences in physical activity promotion in health care settings for primary prevention in the UK

2014 ◽  
Vol 62 (2) ◽  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Health Professionals ◽  
Controlled Trial ◽  
Full Range ◽  
Tertiary Care ◽  
Physical Activity Promotion ◽  
Community Based ◽  
Activity Promotion ◽  
Randomised Controlled

In addition to the delivery of primary care services, recent changes to the NHS in the United Kingdom have placed increasing responsibility on GPs for the commissioning of the full range of health services from prevention through to clinical interventions and rehabilitation. Whilst historically there has always been an expectation that primary care professionals were ideally placed to provide support for prevention as well as treatment, their active engagement in the promotion of physical activity has remained largely superficial. With notable exceptions where individuals have a personal interest or commitment, the majority of health professionals tend to limit themselves to peremptory non-specific advice at best, or frequently don’t broach the subject at all. There are a number of reasons for this including increasing time pressures, a general lack of knowledge, limited evidence and concerns about litigation in the event of an adverse exercise induced event. However in the 1990s there was a surge of interest in the emerging “Exercise on Prescription” model where patients could be referred to community based exercise instructors for a structured “prescription” of exercise in community leisure centres. Despite the continuing popularity of the model there remain problems particularly in getting the active support of health professionals who generally cite the same barriers as previously identified. In an attempt to overcome some of these problems Wales established a national exercise referral scheme with an associated randomised controlled trial. The scheme evaluated well and had subsequently evolved with new developments including integration with secondary and tertiary care pathways, accredited training for exercise instructors and exit routes into alternative community based exercise opportunities.

scholarly journals Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Małgorzata Bartkowiak-Emeryk ◽  
Andrzej Emeryk ◽  
Jacek Roliński ◽  
Ewelina Wawryk-Gawda ◽  
Ewa Markut-Miotła
Keyword(s):  
T Lymphocytes ◽  
Allergic Asthma ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Trial Registration ◽  
House Dust Mites ◽  
Dust Mites ◽  
Bacterial Lysate ◽  
Clinical Trial Registration ◽  
Asthmatic Children

Abstract Background Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate’s action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma. Methods This study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3−CD16+CD56+ were described. Results At baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3−CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased. Conclusions The EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes. Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.

scholarly journals Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
Ángel Luis Rodríguez-Fernández ◽  
...  
Keyword(s):  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Asymmetry Index ◽  
Trial Registration ◽  
Control Group ◽  
Parental Perception ◽  
Positional Plagiocephaly ◽  
Caregiver Education ◽  
Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

scholarly journals A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Yingcai Zhang ◽  
Jiebin Zhang ◽  
Huimin Yi ◽  
Jun Zheng ◽  
Jianye Cai ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Hepatic Failure ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Trial Registration ◽  
Biliary Complications ◽  
Open Label ◽  
Antibody Mediated Rejection ◽  
Link Type ◽  
Induction Strategy

Abstract Background ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. Methods Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. Results No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). Conclusions Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. Trial registration Trial registration: chictr.org.cn, ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074.

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
D. S. Epstein ◽  
J. C. Enticott ◽  
H. J. Larson ◽  
C. Barton
Keyword(s):  
Research Team ◽  
Controlled Trial ◽  
Contact Point ◽  
Research Participation ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Card Game ◽  
Successful Recruitment ◽  
Sensitive Topics ◽  
Randomised Controlled

Abstract Undertaking recruitment for research in schools is an effective way to recruit young people for research participation but it is not without its challenges. Gaining access and coordinating many levels of different organisations and stakeholders whose cooperation and approval are crucial all add time and sometimes logistical challenges for the research team. In addition, recruiting around sensitive research topics can elicit additional barriers to successful research. The research team aimed to conduct a pragmatic cluster randomised controlled trial involving schools in a local government region in Victoria, Australia, to assess the effect of a vaccination-based educational card game called “Vaxcards” on vaccine consent returns. Schools were contacted via phone and email to determine which staff member would best be a contact point for a face-to-face meeting to discuss the methods and purpose of the study. Email follow-ups were scheduled to follow up non-responsive schools and consent forms. The minimum required sample size was 13. Of 31 eligible schools, 13 were recruited. The research team encountered several unanticipated challenges before achieving the recruitment target. The most common reasons for non-participation were being too busy with other commitments, concerns regarding the topic of vaccination being too sensitive, and concerns that key stakeholders in the school would not approve of the research topic of vaccination. One school required a review by a private research ethics board that rejected the study. Significant hesitancy and misinformation about vaccine science was observed that affected engagement with a small number of schools. This paper highlights the challenges of recruiting schools in the context of public anxieties about vaccines and has several important learning lessons for successful recruitment about sensitive topics. This includes navigating approval processes for research in schools, the importance of local champions, dealing with misinformation and the importance of strong relationships and organisational trust. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001753246. Prospectively registered on 25 October 2018 8:24:21 AM

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